Trial · NCT02054104
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
NCT02054104, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2022-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum. Trials, record NCT02054104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02054104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
- NCT number
- NCT02054104
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thoracic Sarcomas, Thorasic Cancers, Cancers of Non-thoracic Origin With Metastases to the Lungs or Pleura, Sarcoma, Melanoma
- Interventions
- H1299 cell lysates, Cyclophosphamide, Celecoxib, Iscomatrix adjuvant
- First posted
- 2014-02-04
- Last updated
- 2022-01-26
- Results first posted
- 2022-01-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Immunologic Responses | one month after the 6th vaccine | Immunologic responses are defined as an appearance of new serologic reactivity, or increase in existing antibody response to cancer-testis on the X chromosome (CT-X) antigen. Antigens such as New York esophageal squamous cell carcinoma-1 (NY-ESO1) and melanoma antigen gene (MAGE) family members assessed by enzyme-linked immunosorbent assay (ELISA) one month after the 6th vaccine. |
| Secondary | Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs | one month after first 6 vaccinations | The Mann=Whitney U test was used to compare the fold change of intensity of PD-1 expression on Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms. |
| Secondary | Fold Change From Baseline of Percent Tregs | one month after first 6 vaccinations | The Mann-Whitney U test was used to compare the fold change of percent Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms. |
| Other | Percentage of T Regulatory Cells at the Two Timepoints: Baseline and End of Treatment | Baseline, and end of treatment | The immunologic response to autologous tumor or epigenetically-modified autologous Epstein-Barr Virus (EBV)-transformed lymphocytes will be determined by the difference, or relative difference, in values (by percentage) of T-regulatory cells at the two timepoints. The percentage of T-regulatory cells will determine if oral cyclophosphamide and celecoxib therapy decreases the percentage of T cells on each Arm/Group. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Immunologic Responses | one month after the 6th vaccine | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs | one month after first 6 vaccinations | fold change | MEAN | |
| SECONDARY | Fold Change From Baseline of Percent Tregs | one month after first 6 vaccinations | fold change | MEAN | |
| OTHER_PRE_SPECIFIED | Percentage of T Regulatory Cells at the Two Timepoints: Baseline and End of Treatment | Baseline, and end of treatment | This exploratory endpoint was not assessed because the trial was suspended after only 1/3rd of the total anticipated patient accrual. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Immunologic Responses | Cohort 1/Vaccine Plus Chemotherapy | 4 | Participants | ||
| Number of Participants With an Immunologic Responses | Cohort 2/Vaccine Alone | 4 | Participants | ||
| Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs | Cohort 1/Vaccine Plus Chemotherapy | 0.84 | Full Range 0.67 to 1.07 | fold change | |
| Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs | Cohort 2/Vaccine Alone | 0.91 | Full Range 0.79 to 1.03 | fold change | |
| Fold Change From Baseline of Percent Tregs | Cohort 1/Vaccine Plus Chemotherapy | 0.87 | Full Range 0.65 to 1.12 | fold change | |
| Fold Change From Baseline of Percent Tregs | Cohort 2/Vaccine Alone | 0.73 | Full Range 0.23 to 1.13 | fold change | |
| Percentage of T Regulatory Cells at the Two Timepoints: Baseline and End of Treatment | Group not reported | Baseline | |||
| Percentage of T Regulatory Cells at the Two Timepoints: Baseline and End of Treatment | Group not reported | End of treatment | |||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Cohort 1/Vaccine Plus Chemotherapy | 8 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Cohort 2/Vaccine Alone | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1/Vaccine Plus Chemotherapy | 10 | |
| Overall Study | STARTED | Cohort 2/Vaccine Alone | 11 | |
| Overall Study | COMPLETED | Cohort 1/Vaccine Plus Chemotherapy | 2 | |
| Overall Study | COMPLETED | Cohort 2/Vaccine Alone | 2 | |
| Overall Study | NOT COMPLETED | Cohort 1/Vaccine Plus Chemotherapy | 8 | |
| Overall Study | NOT COMPLETED | Cohort 2/Vaccine Alone | 9 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort 1/Vaccine Plus Chemotherapy | 1 | 10 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2/Vaccine Alone | 0 | 11 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Cohort 1/Vaccine Plus Chemotherapy | 1 | 10 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Cohort 2/Vaccine Alone | 0 | 11 | 0 |
| other | CPK increased | Investigations | Cohort 1/Vaccine Plus Chemotherapy | 2 | 10 | 2 |
| other | CPK increased | Investigations | Cohort 2/Vaccine Alone | 0 | 11 | 0 |
| other | Creatinine increased | Investigations | Cohort 1/Vaccine Plus Chemotherapy | 0 | 10 | 0 |
| other | Creatinine increased | Investigations | Cohort 2/Vaccine Alone | 1 | 11 | 2 |
| other | Flu like symptoms | General disorders | Cohort 1/Vaccine Plus Chemotherapy | 1 | 10 | 1 |
| other | Flu like symptoms | General disorders | Cohort 2/Vaccine Alone | 1 | 11 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1/Vaccine Plus Chemotherapy | 0 | 10 |
| Total, all-cause mortality | Cohort 2/Vaccine Alone | 0 | 11 |
| Total, other adverse events | Cohort 1/Vaccine Plus Chemotherapy | 8 | 10 |
| Total, other adverse events | Cohort 2/Vaccine Alone | 6 | 11 |
| Total, serious adverse events | Cohort 1/Vaccine Plus Chemotherapy | 0 | 10 |
| Total, serious adverse events | Cohort 2/Vaccine Alone | 0 | 11 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1/Vaccine Plus Chemotherapy vs Cohort 2/Vaccine Alone: Number of Participants With an Immunologic Responses | Trial comparisons |
Cohort 1/Vaccine Plus Chemotherapy vs Cohort 2/Vaccine Alone: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Trial comparisons |
| Cohort 1/Vaccine Plus Chemotherapy vs Cohort 2/Vaccine Alone: deaths from any cause | Trial comparisons |
| Cohort 1/Vaccine Plus Chemotherapy vs Cohort 2/Vaccine Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02054104
GET https://conductscience.org/api/trials/v1/NCT02054104/events?page=2